FDA approves wearable delivery system for Amgen’s Repatha

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug delivery device for Amgen’s Repatha (evolocumab), the company announced Monday. The Pushtronex system is an on-body infusor with a pre-filled cartridge with a 420-mg monthly dose of the cholesterol-lowering drug, one of two new drugs in a class of PCSK9 inhibitors. 

 

“The Pushtronex system exemplifies Amgen's continued innovation and commitment to patients,” Amgen’s EVP research and development Dr. Sean Harper said. “Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration. The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide."

 

Amgen developed the Pushtronex system in collaboration with injectable drug delivery innovation company West Pharmaceutical Services, basing it on West’s SmartDose technology platform. The device allows patients to perform such moderate physical activities as walking, reaching or bending as the drug is being delivered subcutaneously. Drug Store News wrote about SmartDose in April as part of its look at the changing role of wearable technology.  

 

“West is very pleased that Amgen has selected the SmartDose technology platform for the new monthly single dose administration option of Repatha,” West president and CEO Eric Green said. "The combination of Amgen's innovative treatment with West's patient-focused technology platform is an example of how West closely collaborates with our pharmaceutical and biotechnology partners to deliver advanced, integrated solutions for drug delivery and containment."

 

Amgen said it expects for the Pushtronex system to be available in early August. Repatha is also available for delivery every two weeks via a SureClick autoinjector.